Stress Disorders, Post-TraumaticNCT00837109
Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
A study testing Veteran Nightmare Treatment and Treatment-as-usual in people with Stress Disorders, Post-Traumatic and Sleep Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Sleep Disorders
- What is being tested?
- Veteran Nightmare Treatment and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants will be:
- patients at the VA in the Trauma Recovery Program;
- English-speaking;
- reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
- have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
- consenting to be randomized into treatment.
- In addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision and treatment integrity ratings. Participants receiving other forms of group or individual psychotherapy and/or psychotropic medication are eligible for the nightmare treatment condition of the study, provided that those interventions do not specifically target nightmares or PTSD. Thus, the study interventions will be in addition to standard care, except as indicated above.
Who cannot join
- Patients
- with current active suicidal/homicidal ideation and intent;
- with current substance dependence;
- a diagnosis of bipolar or psychosis; 4) prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
- Patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their PTSD symptoms. Patients will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
About this study
Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although trauma-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for veterans.
- Conditions
- Stress Disorders, Post-Traumatic, Sleep Disorders
- Being tested
- Veteran Nightmare Treatment, Treatment-as-usual
- Medical subject headings
- Stress Disorders, Post-Traumatic, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veteran Nightmare TreatmentBehavioural
Veteran Nightmare Treatment Using Imagery Rescripting
Treatment-as-usualBehavioural
Treatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Imagery Rescripting Nightmare Treatment Receives: Behavioral: Veteran Nightmare Treatment |
| 2 | Active comparator | Treatment-as-usual in the Trauma Recovery Program Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
Measured: Baseline, prior to each session, post-assessment, 3-month follow-up
Secondary outcomes (7)
Posttraumatic Cognitions Inventory (PTCI)
Measured: Baseline, post-assessment, 3-month follow-up
Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),
Measured: Baseline, post-assessment, 3-month follow-up
Trauma Related Nightmare Survey (TRNS)
Measured: Baseline, post-assessment, 3-month follow-up
Clinician-Administered PTSD Scale (CAPS)
Measured: Baseline, post-assessment, 3-month follow-up
Modules of the Mini-International Neuropsychiatric Interview (MINI)
Measured: Baseline
Treatment Evaluation Inventory (TEI)
Measured: Post-assessment
Client Satisfaction Questionnaire (CSQ)
Measured: Post-assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Primary investigator is no longer a part of the VA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mary E. Long, PhD, Principal investigator, Michael E. DeBakey VA Medical Center (152)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837109
- Sponsor's protocol ID
- H-24172
- Status last verified
- Sep 2010
- First submitted
- 3 Feb 2009
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Imagery Rescripting Treatment In Veterans With Trauma-Related Nightmares And Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT00837109
- Acronym / sponsor ID
- H-24172
- Conditions
- Stress Disorders, Post-Traumatic, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary investigator is no longer a part of the VA
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research shows that symptoms of posttraumatic stress disorder (PTSD) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with PTSD. This is of concern because people with these problems will often use unhealthy ways of coping. Although trauma-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. One of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. This treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and PTSD, and improved sleep quality and quantity after completing treatment. However, because this treatment has only been studied with civilians, it is not clear how well this treatment works for veterans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Veteran Nightmare TreatmentImagery Rescripting Nightmare Treatment |
| 2 | Active comparator | Behavioral: Treatment-as-usualTreatment-as-usual in the Trauma Recovery Program |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patients at the VA in the Trauma Recovery Program;
- English-speaking;
- reporting at least one Posttraumatic Nightmare in the past week (due to any type of trauma);
- have an existing PTSD International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM); and
- consenting to be randomized into treatment.
Key exclusion criteria (5 listed)
- Patients
- with current active suicidal/homicidal ideation and intent;
- with current substance dependence;
- a diagnosis of bipolar or psychosis; 4) prescribed the medication Prazosin (a psychotropic medication for the treatment of nightmares).
- Patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their PTSD symptoms. Patients will not be excluded if they are taking psychotropic medication (except for Prazosin) and may continue to take their medication as prescribed throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Veteran Nightmare TreatmentVeteran Nightmare Treatment Using Imagery Rescripting | Behavioural | 1 |
| Treatment-as-usualTreatment-as-usual in the Trauma Recovery Program (that does not specifically target PTSD symptoms) | Behavioural | 2 |
Primary outcome
Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II)
Time frame: Baseline, prior to each session, post-assessment, 3-month follow-up
7 secondary outcomes
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Baseline, post-assessment, 3-month follow-up
Pittsburgh Sleep Quality Index-Addendum for PTSD (PSQI),
Time frame: Baseline, post-assessment, 3-month follow-up
Trauma Related Nightmare Survey (TRNS)
Time frame: Baseline, post-assessment, 3-month follow-up
Clinician-Administered PTSD Scale (CAPS)
Time frame: Baseline, post-assessment, 3-month follow-up
Modules of the Mini-International Neuropsychiatric Interview (MINI)
Time frame: Baseline
Treatment Evaluation Inventory (TEI)
Time frame: Post-assessment
Client Satisfaction Questionnaire (CSQ)
Time frame: Post-assessment
Results and safety
The study was stopped early (reason given: Primary investigator is no longer a part of the VA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E. Long, PhD principal investigator
Michael E. DeBakey VA Medical Center (152)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veteran Nightmare Treatment and Treatment-as-usual in people with Stress Disorders, Post-Traumatic and Sleep Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary investigator is no longer a part of the VA). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Stress Symptom Scale-Self-Report (PSS-SR), Beck Depression Inventory-II (BDI-II) (time frame: Baseline, prior to each session, post-assessment, 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2010.